An Open-Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single-dose Crossover Pilot Oral Bioequivalence Study of Ritonavir Capsules 100 mg with NORVIR® Ritonavir Capsules Soft Gelatin 100 mg of Abbott Laboratories, USA in Healthy, Adult, Male, Human Subjects Under Fasting Conditions
Abstract:
Background: The present
study was conducted to investigate the bioequivalence of Ritonavir Capsules 100
mg with that of Norvir® Ritonavir Capsules Soft Gelatin 100 mg.
Patients and methods: This study was
an open-label, balanced,
randomized, two-treatment, two-period, two-sequence, single dose crossover pilot
oral bioequivalence study. Study was conducted in 12 healthy, adult male subjects
with age ranging from 18 to 45 years. The total duration (excluding screening) of
subject participation in a study was approximately 11 days including washout period
of 07 days between each dosing. The estimation of Ritonavir in human plasma is carried
out by using LC/MS/MS method in Bioanalytical laboratory. The pharmacokinetic parameters
assessed were AUC0-t,
AUC0-∞, Cmax, AUC0-t/AUC0-∞, Tmax,
kel and t½.
Results: The geometric
mean ratios (90% confidence intervals) of the test drug/reference drug for Ritonavir
were 100.8 (83.64-121.51) for AUC0-t, 102.1 (85.39-122.01) for AUC0-inf,
and 97.5 (81.19-117.08) for Cmax. The 90% confidence intervals of the
test/reference AUC0-t, AUC0-∞, Cmax ratio of Ritonavir
were within the acceptance range for bioequivalence. In this study, single dose
of Ritonavir 100 mg capsule was well tolerated by both groups of subjects under
fasting conditions.
Conclusion: It was concluded
that the two Ritonavir capsules formulations (the test and reference products) were
bioequivalent in terms of the rate and extent of absorption.
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